01 1SIGMA TAU
02 1Blank
01 1ALPHA-LINOLENIC ACID
02 1LINOLENIC ACID
01 1U.S.A
02 1Blank
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4521
Submission : 1982-04-07
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9260
Submission : 1991-07-22
Status : Inactive
Type : II
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A Alpha-Linolenic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alpha-Linolenic Acid, including repackagers and relabelers. The FDA regulates Alpha-Linolenic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alpha-Linolenic Acid API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Alpha-Linolenic Acid supplier is an individual or a company that provides Alpha-Linolenic Acid active pharmaceutical ingredient (API) or Alpha-Linolenic Acid finished formulations upon request. The Alpha-Linolenic Acid suppliers may include Alpha-Linolenic Acid API manufacturers, exporters, distributors and traders.
click here to find a list of Alpha-Linolenic Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Alpha-Linolenic Acid DMF (Drug Master File) is a document detailing the whole manufacturing process of Alpha-Linolenic Acid active pharmaceutical ingredient (API) in detail. Different forms of Alpha-Linolenic Acid DMFs exist exist since differing nations have different regulations, such as Alpha-Linolenic Acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Alpha-Linolenic Acid DMF submitted to regulatory agencies in the US is known as a USDMF. Alpha-Linolenic Acid USDMF includes data on Alpha-Linolenic Acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Alpha-Linolenic Acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Alpha-Linolenic Acid suppliers with USDMF on PharmaCompass.
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